Senior Qualification Specialist

Johnson & Johnson

Schaffhausen, Switzerland
**
Equipment qualification and re-qualification
Computer system validation (csv)
Data integrity controls
** Johnson & Johnson is seeking a Senior Qualification Specialist in Schaffhausen, Switzerland, to lead qualification and computer system validation (CSV) activities for Quality Control laboratories. The role emphasizes data integrity, regulatory compliance, and cross-functional collaboration in a pharmaceutical environment. **

Job Summary

  • Johnson & Johnson Innovative Medicine is seeking a Senior Qualification Specialist to lead and execute qualification and computer system validation (CSV) activities for Quality Control (QC) laboratories.
  • You will drive lifecycle management of analytical instruments and non-analytical utilities, ensuring data integrity and regulatory compliance across systems.
  • The role involves authoring and revising WIs/SOPs, planning and steering qualification campaigns, and investigating/closing DI/CSV deviations with effective CAPAs.

Matching Summary

Match Score: 75

** Johnson & Johnson is seeking a Senior Qualification Specialist in Schaffhausen, Switzerland, to lead qualification and computer system validation (CSV) activities for Quality Control laboratories. The role emphasizes data integrity, regulatory compliance, and cross-functional collaboration in a pharmaceutical environment. **

Skills & Requirements

Must-have

  • equipment qualification and re-qualification
  • Computer System Validation (CSV)
  • data integrity controls
  • GMP and site standards
  • lifecycle management of analytical instruments

Nice-to-have

  • cross-functional project teams
  • work-life balance
  • collaboration with internal partners
  • support for ongoing development

Key Requirements

  • MSc or PhD in Natural Sciences, Engineering, Computer Science, or related field
  • Bachelor’s degree with substantial, relevant GMP experience
  • Proven experience qualifying laboratory equipment in a GMP environment
  • Hands-on CSV experience for laboratory/software systems
  • Fluent English; German at B1 or higher desirable

Work Rights

Not specified

Tailored Resume

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